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When Your Product Quality Matters Most PHARMACEUTICAL ENVIRONMENTAL MONITORING

When Your Product Quality Matters Most · BIOMERIEUX, the blue logo, 3P, LockSure, Bi-Box, Count-Tact are used, pending and/or registered trademarks belonging to bioMérieux or one

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Page 1: When Your Product Quality Matters Most · BIOMERIEUX, the blue logo, 3P, LockSure, Bi-Box, Count-Tact are used, pending and/or registered trademarks belonging to bioMérieux or one

When Your Product Quality Matters Most

P H A R M AC E U T I C A L E N V I R O N M E N TA L M O N I TO R I N G

Page 2: When Your Product Quality Matters Most · BIOMERIEUX, the blue logo, 3P, LockSure, Bi-Box, Count-Tact are used, pending and/or registered trademarks belonging to bioMérieux or one

Measuring the effectiveness of contamination control is an essential component for environmental risk management. Accurate environmental monitoring data is crucial when making product release decisions.

Culture media must be robust enough to withstand the rigorous conditions in today’s pharmaceutical cleanrooms. Culture media needs to be both reliable and sensitive to reliably detect stressed organisms inherent to aseptic manufacturing areas.

With over 50 years of microbiology experience, bioMérieux has developed a solution specifically designed for pharmaceutical environmental monitoring….

l Validated with comprehensive thermal shocks during shelf-life testing to guarantee consistent performance from the beginning of the shelf-life to the date of expiry

l Developed using both pharmacopoeia and wild-type strains from real clean room environments – to easily express stressed organisms

l Completely controlled manufacturing process from the basic raw materials, to the final plate, ensures consistent reliability between all batches.

The 3P™ range represents state-of-the-art culture media

technology from both a formulation and

packaging perspective

the 3P

™ range.

Page 3: When Your Product Quality Matters Most · BIOMERIEUX, the blue logo, 3P, LockSure, Bi-Box, Count-Tact are used, pending and/or registered trademarks belonging to bioMérieux or one

l Maximum convenience for storage and inventory management - Flexible storage between 2 - 25°C - Long shelf-life

- Large monolot capacity

l Validated with Vaporous Hydrogen Peroxide (VHP) and Peracetic Acid gassing cycles for isolator compatibility

l Secure your crucial Environmental Monitoring samples during critical transport and incubation steps with bioMérieux’s unique LockSure® 90mm closure system

- Quick and intuitive use – single locking position

- No need for additional parafilm or adhesive tape wrapping of plates – saves time and reduces risk

PROVENValidated for use by

pharmaceutical manufacturers world-wide for

their most critical manufacturing environments

PERFORMANCEMedia formulations

optimised for maximum sensitivity and reproducibility

within the same lot, and from batch to batch

PHARMACEUTICALDesigned to meet the

pharmaceutical industry’s needs for the highest quality culture

media for use in clean room and isolator manufacturing areas.

LockSure® closure system

Page 4: When Your Product Quality Matters Most · BIOMERIEUX, the blue logo, 3P, LockSure, Bi-Box, Count-Tact are used, pending and/or registered trademarks belonging to bioMérieux or one

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bioMérieux Industry595 Anglum RoadHazelwood, MO, 63042U.S.A.Tel.: (314) 731-8500Fax: (314) 731-8678

www.biomerieux-usa.com

Microbial Control Solutions for Pharmaceutical and Biotechnology Industries

Description Reference Presentation StorageCount-Tact® 3P™ 410250 2 x 10 65mm 2-25°C

Count-Tact® 3P™ 418049 10 x 10 65mm 2-25°C

TSA 3P™ Locksure® 410251 2 x 10 90mm 2-25°C

TSA 3P™ Locksure® 418140 10 x 10 90mm 2-25°C

3P Culture Media

Complete, practical and reliable aerobio contamination control utilizing the impaction air sampling method

Triple wrapped and irradiated nylon flocked swab enables improved recovery from irregular surfaces

Easy to use with unprecedented accuracy for Quantitative Microbiological Quality Control

Automated system for routine microbial identification delivering results within 2 to 18 hours

Revolutionizing microbial identification with GMP compliance, secured knowledge base and results in minutes

Quantiswab®